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Randstad US CAPA Engineer in Andover, Massachusetts

CAPA Engineer

job details:

  • location:Andover, MA

  • salary:$26.66 - $39.32 per hour

  • date posted:Wednesday, October 13, 2021

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:876864

job description

CAPA Engineer

job summary:

A CAPA Engineer is needed for a leader in electronics, healthcare, and lighting. This position is Remote. Candidate should have a Bachelor's degree in engineering, science or related field and Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001.

location: Remote, Remote

job type: Contract

salary: $26.66 - 39.32 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

  • Facilitate Corrective and Preventive Action (CAPA) and nonconformance (NC) investigations from issue identification through the implementation of solution and effectiveness monitoring.

  • Project manage all aspects of CAPA and NC activity which includes gaining the commitment of cross-functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

  • Mentor CAPA teams with the implementation of appropriate root cause analysis techniques (e.g. Fishbone, Pride problem solving).

  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

  • Work effectively with all levels of management to ensure CAPA action plans can be supported and resources needed to implement the plan are available.

  • Independently produces and completes robust CAPA records (FTR).

  • Responsible for performing timely, detailed CAPA engineering tasks such as: assessing issue descriptions, reviewing CAPA data sources, conducting verification and validation activities for the action plan, assisting with root cause analysis and quality problem solving

  • Escalate issues that prevent CAPAs and NCs from being properly addressed

Qualifications:

Required:

  • Bachelor's degree in engineering, science or related field.

  • Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001

  • At least 5+ years of experience in a medical device industry

  • Excellent people and communication skills, including the ability to express technical concepts in verbal and written form

  • Comfortable in a dynamic and evolving environment

  • Able to influence without authority

  • Analytical mindset. Focuses on the details while seeing the big picture.

  • Able to solve complex problems by bringing ideas into action.

  • strong project management, collaboration,?and organizational skills

  • strong aptitude for coordinating and assigning tasks

  • Enthusiastic, motivated and self driven

Preferred:

  • Quality Auditor Experience

  • Lean Six Sigma certification or working knowledge

  • Global project management experience. PMP a plus

qualifications:

  • Experience level: Experienced

  • Education: Bachelors

skills:

  • Quality

  • Medical Device

  • CAPA

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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